A PROJECT REPORT ON PRACTICE SCHOOL A Report Submitted in Partial Fulfillment of Requirements for the course BACHELOR OF PHARMACY in Field of Pharmacy by Arjun Singh 2109870500015 ) Under the Supervision of Dr. Manjul Vishveshwarya College of Pharmacy to the Faculty of Pharmacy DR. A.P.J. ABDUL KALAM TECHNICAL UNIVERSITY LUCKNOW (Formerly Uttar Pradesh Technical University, Lucknow) August, 2024VISHVESHWARYA GROUP OF INSTITUTIONS ‘fated AKTU, Woknow (UP) | COS Un Technical Campus Approved by AICTE / UGC /PCi/BTE BCI Approved by Merity of Edueaton, Govt of na eed ed wn o DECLARATION I Arjun Singh. hereby declare that this report entitled “Formulation and evaluation of Skin Protective Gel by using Traditional Triphala » submitted to Dr. A.P.J. Abdul Kalam Technical University, Uttar Pradesh, Lucknow, in the Partial Fulfillment of The Requirements for The Degree of Bachelor of Pharmacy (B. Pharm. 7 Semester) is a genuine record of work done by me, under supervision of ....Ms. Meenakshi Singh... STUDENT-TRAINEE Mr. Arjun Singh. B. Pharm. 7" Semester Roll. No:- 2109870500015,VISHVESHWARYA GROUP OF INSTITUTIONS a y. Iiated to AKTU, Lucknow (UP) | GCS University Moerat (UP) amr soon Technical Campus, Approved by AICTE / UGC / PCI / BTE / BCI aN Approved by Ministry of Education, Govt. of Inca yr] Academic Excellence This is to certify that this report entitled “Formulation and evaluation of Skin Protective Gel by using Traditional Triphala.” submitted to Dr. A.P.J. Abdul Kalam Technical University, Uttar Pradesh, Lucknow, in partial fulfillment of the requirements for the degree of Bachelor of Pharmacy (B. Pharm. 7" Semester) is a bonafide record of work done by Mr:-. ... Arjun Singh. .....under my supervision during B. Pharm, 7 Semester (2024). *Name and sign of Principal *Name and sign of SupervisorContent [Link] .. Introduction Formulation Evaluation Results Conclusion References[Link] » Formulation and evaluation of Skin Protective Gel by using Traditional Triphala. 2. Introduction. v Triphala is a combination of three medicinal plants, Amalaki Phyllanthus emblica (syn. Emblica officinalis) Phyllanthaceae family, Haritaki (Terminalia chebula) Combretaceae family, and Bahera (Terminalia bellirica) Combretaceae family, and has been extensively used in Ayurveda since ancient times. It is a very useful tool for improving the body’s immunity, as it readily promotes the body’s ability to form antibodies in order to fight any invasion of antigens. Amalaki is an excellent source of vitamin C and also contains carotene, nicotinic acid, D-glucose, D-fructose, riboflavin, empicol, and mucic and phyllemblic acids. Haritaki is used in traditional medicine due to the wide spectrum of pharmacological activities associated with the biologically active chemicals present in this plant. It contains anthraquinone glycoside, chebulinic acid, tannic acid, terchebin, vitamin C, and arachidonic, linoleic, oleic, palmitic, and stearic acids. It inhibits the rate of cell proliferation and cell death in cancer cell lines. Bahera contains chebulagic acid, ellagic acid and its ethyl ester, gallic acid, fructose, galactose, glucose, mannitol, and thamnose. > © Terminalia bellirica is a deciduous tree of the family Terminalia that has an antiviral effect on bacteria and a variety of diseases. Therefore, many studies have been conducted on the antibacterial activity of Terminalia bellirica, mainly in E. coli, and yellow staphylococcus. However, studies on Terminalia bellirica in relation to skin wrinkle improvement or elasticity improvement effects are limited. Phyllanthus emblica L., Indian gooseberry or amla, is known as the “fruit of rejuvenation” and has the effect of preventing various diseases and aging, is essential for beauty and health, and contains a large amount ofvitamin C and polyphenols to prevent cell oxidation and reduce free radicals. The antioxidant function of vitamin C prevents cells from being destroyed from excess free radicals, inducing the secretion of insulin-like growth factor-1 (IGF-1), which promotes skin improvement, and. inhibiting the secretion of factors such as DKK-1 and TGF-11, thus helping the skin stay healthy. 3. Literature revie > Haritaki Latin name - Terminalia chebula Linn. Family - Combretaceae Classical name - Haritaki Sanskrit synonyms - Haritaki, Pathya, Abhaya, Avyatha, Vayastha, Haimavati, Shiva Hindi name - Harre, Harad English name - Chebulic Myrobalan > Swaroopa (Habit) - A moderate sized / large deciduous tree Habitat - Found in MP, W. Bengal, Karnataka and Maharashtra in India, Burma and Ceylon Types - Seven types namely Vijaya, Rohini, Putana, Amrita, Abhaya, Jivanti and Chetaki Ayurvedic Pharmacodynamics Rasa - Pancharasa (Kashaya predominance, Lava rahita) Guna - Laghu, Ruksha Virya - Ushna Vipaka - Madhura Prabhava - Tridoshahara Dosha karma - Mainly kapha pitta samaka.Chemical Composition Fruit contains tannin up to 30 %, chebulic acid and gallicacid and some purgative constituents of the nature of Anthraquinone. Therapeutic Uses:- The fruit is the prominent herbal drug, commonly and widely used in Indian system of Medicine and is afrequent addition in a large number of formulations. It is useful in asthma, sore throat, thirst, vomiting, eye disease, heart and bladder diseases, strangury, urinary discharges, as inflammation, bleeding piles, typhoid, constipati and delirium. The ripe fruit are purgative, tonic, carminative and strengthens the brain, eyes and gums. The unripe fruit is astringent and useful in dysentery and diarrhoea. >» Vibhitaki:- Latin name - Terminalia bellerica Roxb. Family - Combretaceae © Chemical Composition:-Fruit contains:- 17% tannin and gallo- tannic acid (colouring matter) and resin. Seeds contain greenish yellow oil. Therapeutic Uses:- The bark is beneficial in asthma and [Link] fruiit is digestible, laxative and antihelminthic and is employed for bronchitis, sore throat, biliousness, inflammation and in diseases of eye, nose, heart and urinary bladder. The oil is a good application for the hair.On the fresh cuts and wounds, the fine powder is dusted to arrest bleeding as an astringent and styptics agent. The fruit of the Beleric myrobalan forms an ingredient of an important group of three myrobalans (viz. embelic, beleric and chebulic myrobalans) popularly known as Triphala. Latin name - Emblica officinalis Gartn. Family - Euphorbiaceae Classical name - Amalaki, Dhatri Hindi name - Awala, Amla, Aonla Sanskrit synonyns - Amalaki, Dhatri, Vyastha English name - Indian gooseberry Habitat - Found throughout India; often planted in gardens and cultivated also in small and large scale > Ayurvedic Pharmacodynami Rasa - Pancharasa (Amla predominance and Lavanarahita) Guna - Laghu, Ruksha, Sita Virya - Sita Vipaka - MadhuraPrabhava - Rasayan Dosha karma - Tridoshhara, Pittasamaka (mainly) > Parts use its := Chemical Composition ;Fruit is a well known rich source of Vitamin C. Seeds contains fixed oil, phosphatides and an essential oil. Fruits, barks and leaves are rich in tannins. » Therapeutic Uses Fruits are the most useful part of the plant and are used medicinally in various diseases adopting different forms. Fruits are used for supplementing Vitamin C and other contents also. It is one of the most popular, common and highly reputed drugs of indigenous system of medicine. It is used in anemia, hyperacidity, peptic ulcer, dyspepsia, anorexia, diarrhoea, dysentery, hemorrhage, eye inflammations, irritability of bladder, leucorrhoea, spermatorrhoea, epitaxis’, menorrhagia, jaundice, weak memory condition, nervine debility, oedema and liver condition. The juice of fresh fruit is given as tonic, refrigerant and antiscorbutic, diuretic, laxative and anti The ancient authors classified the drugs in different gana, varga and skanda ete. The drugs have been classified on the basis of their morphological characters, properties and pharmacodynamic as well as therapeutic values. (Table 2) Types of Triphala :- Nighantu has mentioned three types of Triphala- ¢ Swalpab Triphala:-Draksha, kharjura, parushaka; these three fruits together is called Swalpa Triphala « Madhura Triphala Draksha, kharjura, kasmarya; these three fruits together is called swadu Triphala. It is beneficial to vision, appetizer, promotes desire for food, and useful in alleviating irregular fever. « Sugandhi Triphala :- Jatiphalam, ela, lavangam; these three constitute is called Sugandhi Triphala. It is astringent, sweet in vipaka and useful in breaking constipation due to kapha and vata doshas. « Pharmacological Activities :- Triphala classified as an important medicine of the Rasayana group and is believed to promote health, immunity and longevity and frequently used to treat chronic ulcer and it is an antioxidant rich herbal formulation. The aqueous extract of Triphala is reported as antigastric ulcer and anti- peptic activity, good radio- Bali chouhan et al / Int. J. Res. Ayurveda Pharm. 4(4), Jul — Aug 2013 protective agent against gamma radiation and cytotoxic tohuman breast cancer cell [Link] extacts of triphala reported to exhibitedantimutagenic activity, reduce damage due to oxidative stress, posse activity and free radical scavengers, cytotoxic and apoptotic agent against breast cancer cells and prostate cancer and possess antibacterial activity. The powder of Triphala reported as promising anti- sustained anti-diabeticinflammatory and anti arthritic drug and as potent and novel therapeutic agents for scavenging of nitric oxide, as a cardio tonic drug which is also prescribed for symptoms of inflammation, heat, infection, obesity, anaemia, fatigue, Candida, poor digestion, assimilation, tuberculosis, pneumonia and AIDS. ¢ Traditional Uses of Triphala :- In Ayurvedic practice, Triphala is used for gastric disorders such as digestion problems, poor food assimilation ,cleansing of colon, constipation and tonifier of the GIT and [Link] the gastrointestinal tract and colon. It is also recommended to be used for cardiovascular disorders, high blood pressure, serum cholesterol reduction, ophthalmic problems, liver dysfunction, inflammation and complications of the large intestine. It is also used as a blood purifier, to improve the mental faculties and is reported to posses anti-inflammatory, analgesic, anti arthritic, hypoglycemic and anti-aging properties. « Pharmacology and Clinical Studies :- Reported Activities of Triphala as [Link] Ratio - I. Antihyperlipidemic effect of Triphala Rats which were fed with a diet consisting of 4 %Cholesterol, 1 % cholic acid and egg yolk for forty eight resulted in a significant increase in the total cholesterol, LDL, VLDL and FFA making them hypercholesteremic. But administration of Triphala at 1g/kg body weight for 48 days caused significant reduction in total cholesterol, LDL, VLDL and FFA. Il. Free Radical scavenger :- Triphala has been found to be an excellent scavenger of hydroxyl radicals and superoxide radicals, peroxy radicals, Hydroxyl radicals and nitric oxideradicals. Naik et al. estimated the total free-radical scavenging ability of Triphala by employing non-biological and stable free radicals like 2,2- diphenyl-1-picrythydrazy (DPPH) and 2,2'-azino-bis (3- ethylbenzthiazoline-6- sulphonic acid (ABTS) antioxidant and radio protecting ability of Triphala arise from the polyphenols, which reduce oxidative stress by converting the reactive oxygen free radicals to non-reactive products. In another study Naik et al. revealed that all three constituents of Triphala are active. E. officinalis shows greater efficiency in LPO and plasmid DNA assay, while T. chebula has greater radical scavenging activity. Thus their mixture, Triphala, is expected to be more efficient due to the combined activity of the individual components Il. Immunomodulatory effect Study by Srikumar et al. have shown that administrationof Triphala enhanced the phagocytosis, phagocytic index, antioxidant activities and decreased corticosterone levels in animals exposed to noise stress. IV. Anti-inflammatory and anti-arthritic effects activity Rasool et al. evaluated the anti arthritic effect of Triphala. The physical and biochemical changes observed in arthritic animals were altered significantly to near normal conditions after oral administration of Triphala (1 g/kg/bw). In another study Rasool studied the efficacy of Triphala on monosodium urate crystal-induced inflammation in mice where significant inhibition in paw volume, levels of lysosomal enzymes, LPO and inflammatory mediator tumour necrosis factor-a was found(inflammatory mediator) V. Analgesic, antipyretic and ulcerogenic activities :-The analgesic, antipyretic and ulcerogenic activities of Triphala (500/1000 mg/kg bw) were compared with thenon-steroidal anti-inflammatory drug Indomethacin (10 mg/kg bw) on the experimental models in mice and it was found that Triphala at both the dose levels produced excellent analgesic and antipyretic effect, without any gastric damage. VI. Anticancer Activity:- The use of Triphala in diet has been shown to significantly reduce the benzo (a) pyrene induced stomach papillomagenesis in mice. It was observed that the concomitant use of multiple agents seemed to have a high degree of chemoprevention potential. Vil. . Wound Healing: Several studies support the wound-healing capacity of Triphala. Haritaki, in particular, promotes tissue regeneration and accelerates the healing of wounds. A study published in the Journal of Surgery (2013) found that Triphala significantly enhanced the rate of wound closure, collagen deposition, and re- epithelialization... VUI. Antimicrobial and Antibacterial Effects: Triphala exhibits strong antibacterial activity against a range of pathogens, including Staphylococcus aureus and Escherichia coli, which are commonly responsible for skin infections. A 2015 study in the Journal of Ayurveda and Integrative Medicine demonstrated that Triphala can inhibit the growth of acne-causing bacteria, making it a potent natural treatment for acne and similar bacterial skin issues. IX. _Anti-aging Properties: Triphala’s antioxidant and collagen-boosting properties make it beneficial for anti-aging skincare. By neutralizing free radicals and promoting collagen production, Triphala can reduce the appearance of fine lines, wrinkles, and sagging skin, thereby improving overall skin tone and texture.4. Materils and metho 1. Standardized Triphala Extract:- The standardized TC fruit extract used in this study is a commercially available material from Sytheon Ltd. called Synastol® TC, which is standardized against hydrolysable tannins (70%) containing two key bioactive phytochemicals, including chebulinic acid (220%) and chebulagic acid (10%) and having a free gallic acid content <5%. The in vitro methods followed to measure the performance of Standardized TC fruit extract to neutralize ROS were based on previously published methods.!=!S Determination of Long-Lasting Antioxidant Effectiveness Standardized TC fruit extract and a-Tocopherol (4-TOC) were solubilized in 50% aqueous ethanol or ethanol, respectively, placed in quartz cuvettes and then exposed to solar-simulated UV radiation (UVR) at 6.51 mW/cm? over 4 hours using a Rayonet RPR-100 photochemical reactor (Southern New England Ultraviolet Company), which simulates day light conditions. Aliquots of the solutions were removed at varying times (0, 15 min, 30 min, | hr, 2 hr and 4 hr) corresponding to UVR doses of 5.9, 11.7, 23.4, 46.9 and 93.7 J/cm? and antioxidant capacities (AOC) of the solutions to neutralize peroxyl radicals were determined using Hydro ORAC method for the standardized TC fruit extract and lipophilic ORAC method for a-tocopherol as described previously. Long- lasting effectiveness was then equated with the extent to which AOC remained after each exposure to UVR and was calculated using the following equation:« Ingredients: That are being used to prepare Triphala Gel: (Around 30g) 1. Triphala Extract (or Triphala Powder): 5-10% (for its therapeutic effects)~1.5g 2. Carbopol 940: 0.5-1% (for gel formatio 0.3g 3. Glycerin: 3-5% (acts as a humectant, providing skin moisture)~0.9 4. Triethanolamine (TEA): 0.5-1% (to neutralize ph and thicken Carbopol) 5. Distilled Water: 85-90% (as the solvent base)~26.5ml 6. Preservatives: e.g., Methylparaben or Phenoxyethanol (0.1-0.2% to ensure microbial stability) 7. Fragrance or Essential Oil (optional): 0.1-0.5% (for aesthetic appeal).~2-4 drops 5. Formulation:- Procedure:- a) Preparation of Carbopol Gel Base:~ > Weigh the required amount of Carbopol 940 (0.5-19). Ensure the weight is precise, as small variations can affect gel [Link] Carbopol in distilled water: Slowly add Carbopol 940 to a beaker containing approximately 85-90% of distilled water. Stir the solution gently (using a magnetic or mechanical stirrer) to avoid clumping. Continue stirring until Carbopol is fully dispersed, forming a homogenous mixture. This step may take around 15-20 [Link] the Carbopol dispersion to hydrate for at least 1 hour for optimal thickening. b) Prepare the Triphala Powder:-> Ifusing Triphala powder: Mix the powder with a small portion of illed water (5-10%) and stir well to form a solution. Alternatively, Triphala extracts can be directly added without further preparation. Filter the Triphala solution (if using powder) to remove any undissolved particles to ensure a smooth final gel texture. c) Incorporate Glycerin:- ® Add glycerin (3-5%) to the Carbopol dispersion. Glycerin acts as a humectant, drawing moisture to the skin, which helps maintain skin hydration and prevents drying caused by the astringent properties of Triphala. d) Neutralization with Triethanolamine (TEA):- > — Gradually add Triethanolamine (0.5-1%) dropwise to the Carbopol mixture while stirring continuously. TEA helps to neutralize the Carbopol, which results in thickening and formation of a gel-like [Link] the pH: Use a pH meter to ensure the pH of the gel is within the range of 5.5-6.5, which is skin-friendly and optimal for Triphala’s [Link] stirring until the gel becomes clear and homogenous. Add Triphala Solution to the Gel:- > Slowly add the prepared Triphala extract (or solution) into the Carbopol gel base. Stir the mixture gently but thoroughly until the Triphala is evenly distributed in the [Link] using powdered Triphala, ensure that it is well mixed without forming any lumps. Incorporate Preservatives:Add a preservative such as Sodium Benzoate at a concentration of 0.1-0.2%.¢. Ph evaluation (5.5-6.5)6. Evaluation: 3. Evaluation of physicochemical properties- ae y urs The formulation's pH is assessed to ensure compatibility with the skin's natural acidic mantle. Viscosity:- Rheological measurements determine the gel's viscosity for optimal spreadability and application. iii. Appearance: The gel's color, clarity, and overall aesthetic appeal are evaluated for consumer acceptability. iv. Homogeneity;- Visual inspection and microscopic analysis confirm the uniform distribution of the Triphala extract. 7. Results:- The skin protective gel by using the Traditional Triphala was formulated and evaluated which weighed around 30g and ph evaluation was between the range of 5.5-6.5. Formulation | Appearance | Clarity Batch Dark Clear brown Formulation | Ph _| Viscosity | Spreadability | Homogeneity Batch 5.5- | Low excellent Homogenous 6.5 _| viscosity8. Conch The use of Triphala churna in gel form offers promising benefits for skin health due to its potent antioxidant, anti-inflammatory, antimicrobial, and anti-aging properties. Several studies support the efficacy of Triphala-based gel formulations in wound healing, skin rejuvenation, and the management of inflammatory skin conditions. Its ability to neutralize free radicals, promote collagen production, and soothe irritated skin makes it a valuable ingredient in natural skincare products. However, more research is required to optimize gel formulations and fully understand the long-term effects of topical Triphala use on various skin types. 4. Potential Side Effects and Considerations: While Triphala is generally considered safe for topical application, some individuals may experience allergic reactions or irritation, particularly if they have sensitive skin. It is recommended that a patch test be conducted before regular use. Additionally, the concentration of Triphala in the gel should be carefully balanced to avoid potential skin dryness due to its astringent properties. = References:- 1. Srikumar R, Parthasarathy NJ, Shankar EM, et al. "Evaluation of the growth inhibitory activities of Triphala against common bacterial isolates from HIV-infected patients.” Phytotherapy Research. 2007.2. Jadhav AM, Girase MV, and Shelke PA.Le wa ae ta "Formulation and evaluation of Triphala extract-based hydrogel for wound healing.” International Journal of Research in Pharmaceutical Sciences. 2018. Anbarasu K, Raja A, Ranjan S. "Antimicrobial activity of Triphala on common acne-causing bacteria.” Journal of Ayurveda and Integrative Medicine. 2015. Patil S, Katteker S. "Evaluation of anti-aging and moisturizing effects of Triphala-based herbal gel.” Journal of Cosmetology and Dermatology. 2019. . Rajasekaran Aiyalu et. al (2016) Formulation and evaluation of topical herbal gel for the treatment of arthritis in 566 animal [Link] Journal of Pharmaceutical Sciences: 493-507. Andra, S.; Balu, S.; Ramoorthy, R.; Muthalagu, M.; Manisha, V.S. Terminalia bellerica fruit extract mediated synthesis of silver nanoparticles and their antimicrobial activity. Mater. Today Proc. 2019 Pandey, G.; Gupta, S.S.; Bhatia, A.; Sidhu, O.P.; Rawat, A.K.S.; Rao, C.V. Grilling enhances antidiarrheal activity of Terminalia bellerica Roxb. fruits. J. Ethnopharmacol, 2017.